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Clinical Notes

Komen-Funded ASCO Workforce Study Will Examine Role of Non-Physician Practitioners

The American Society of Clinical Oncology has commissioned a new study, funded by Susan G. Komen for the Cure, to assess how nurse practitioners and physician assistants and other non-physician practitioners health care professionals can provide vital services to cancer patients as part of continued efforts to address the projected future oncology workforce shortages.

The study, to be conducted by Oncology Metrics, will be, a news release notes, a comprehensive analysis of how oncology practices provide patient care, through collaborative care teams made up of oncologists, nurse practitioners, and physician's assistants. Some 40 private and hospital-based oncology practices will be examined, looking at satisfaction, efficiency, and productivity, with the aim of establish “best practices.”

“ASCO and the Workforce Advisory Group continue to explore a variety of solutions to the anticipated oncology workforce shortage,” said ASCO President Douglas W. Blayney, MD. “We believe collaborative practice models will help cancer care professionals cope with the realities of having too many patients and not enough doctors.”

The shortage is related to the following situations: The number of Americans age 65 and older will double by 2030 as baby boomers age. At the same time, people are living longer with cancer, requiring ongoing care. A 2007 ASCO workforce study said that demands for visits will increase by 48% by 2020, but the number of oncologists will be 4,000 fewer than needed.

“This is a real problem that must be addressed and soon,” said Komen President and CEO Hala Moddelmog. “That's why Komen is investing $10 million into this effort and others, to find solutions to these big issues in cancer care, including critical access issues and research to deliver treatments more effectively.”

The practices included in the survey will vary in size, patient population, and location. “This study will enable us to address the unique problems oncology practices are facing across the country and potentially offer some solutions,” Dean Bajorin, MD, Co-Chair of ASCO's Workforce Advisory Group, noted in the news release “Obviously, a small rural practice will have different needs than a large practice in an inner city.”

And Michael Goldstein, MD, the other Co-Chair of the Workforce Advisory Group, said that while oncologists will continue to provide hands-on patient care, integrating nurse practitioners and physician's assistants has significant potential to extend the supply of oncologist services, particularly in the care for the growing number of cancer survivors.

Chemoselection Shown as Feasible Organ-Preservation Alternative to Total Laryngectomy

Some patients with large laryngeal squamous cell cancers can have their speech preserved with chemotherapy and radiation instead of having a total laryngectomy. That was the conclusion of a study by researchers from the University of Michigan Comprehensive Cancer Center, now available online ahead of print in The Laryngoscope, which found that a single round of chemotherapy could identify those patients most likely to benefit from this approach.

“Organ preservation studies have excluded these patients because their tumors are so large,” lead author Francis P. Worden, MD, Associate Professor of Internal Medicine, said in a news release. “We found that if a patient's tumor does not respond to chemotherapy, the patient can be instantly referred for a laryngectomy, which is the standard of care. But if the tumor responded to the drugs, perhaps some of those people could survive the cancer with their voice box intact.”

He and her colleagues reviewed data from two University of Michigan studies of advanced laryngeal cancer patients, looking specifically at those with T4 tumors. Study participants were given one round of induction chemotherapy, and if the tumor shrank by more than half after that first round, the patients were given three more rounds of chemotherapy, combined with daily radiation therapy. Those whose tumors did not respond to the induction chemotherapy were referred for surgery.

Of the 36 patients enrolled, 29 (81%) responded, and many had their tumors shrink completely, the researchers reported. After three years, 28 patients (78%) were still alive, and 21 (58%) still had an intact larynx.

“If the patient failed chemotherapy up front, he or she could go straight to surgery and avoid the side effects of chemoradiation,” Dr. Worden said. “Meanwhile, a large group of patients get to preserve their voice box by avoiding laryngectomy. We saw no survival difference between the smallest and the largest tumors, which suggests that organ preservation is a viable alternative to surgery for some of the largest laryngeal cancers.”

The study is the full journal report of an abstract presented at the 2007 ASCO Annual Meeting and then updated at the 2008 International Conference on Head and Neck Cancer.

HHS Secretary Sebelius Releases New Report on the “Hidden Costs of Health Care”

Department of Health and Human Services Secretary Kathleen Sebelius has released a new report, “Hidden Costs of Health Care: Why Americans are Paying More but Getting Less,” which documents the rising cost of deductibles, co-payments, and out-of-pocket expenses that are making it more difficult for families with insurance to receive the health care they need

“It doesn't matter if you have insurance or not: when Americans go to the hospital or the doctor's office, they are paying more and getting less,” Secretary Sebelius said in a statement. “Every year, co-pays, deductibles, and other expenses are taking a bigger bite out of the family budget, and the American people are demanding reform.”

Among the major findings in the report:

* A person with employer-based coverage paid an average of $1,522 on health care (not including premiums) in 2006, compared with $1,260 in 2001. When including the added burden of higher premiums, out-of-pocket costs rose even more sharply, with a 30% increase from an average of $2,827 in 2001 to $3,744 in 2006.

* Employer-sponsored health insurance premiums have nearly doubled since 2000, a rate three times faster than wages. In 2008, the average premium for a family plan purchased through an employer was $12,680, nearly the annual earnings of a full-time minimum wage job.

* For preferred provider organization plans purchased through an employer, the average family deductible increased 30% in just two years, from $1,034 to $1,344. This effect is more pronounced for small firms, where PPO deductibles increased from $1,439 to $2,367, a rise of 64%.

* In 2004, only one in five people with health insurance through an employer had a co-payment of more than $25, but by 2008 the number jumped to one in three.

“Millions of Americans don't have insurance, and millions more are still struggling to afford the care they need, Secretary Sebelius said. “We need to pass health reform this year to give these families the relief they need.”

The report is one of a series of reports on the health care status quo, all available online at www.healthreform.gov.

First Cancer Treatment for Dogs Approved

Palladia (toceranib), the first drug developed specifically for the treatment of cancer in dogs, has been approved by the FDA. Toceranib phosphate is approved to treat canine cutaneous mast cell tumors with or without regional lymph node involvement.

The tyrosine kinase inhibitor works in two ways by killing tumor cells and by cutting off the blood supply to the tumor. In a clinical trial, the drug showed a statistically significant difference in tumor shrinkage when compared to placebo. The most common side effects are diarrhea, decrease or loss of appetite, lameness, weight loss, and blood in the stool.

New Web Resources Available for Cancer Patients

Several cancer organizations have launched new Web sites to help cancer patients deal with financial and emotional issues related to their disease.

The Cancer Financial Assistance Coalition (CFAC), a group of 12 advocacy and service organizations that provide resources to cancer patients to help with the costs associated with their treatments, has launched a new Web site providing financial assistance information online. The site, www.cancerfac.org, allows users to search for assistance either by cancer diagnosis or by type of aid needed, and from there users are presented with a list of national and regional organizations that may be able to provide relief.

In honor of National Cancer Survivor's Day (June 7), the National Coalition for Cancer Survivorship created a new online community for cancer survivors, their caregivers, and their loved ones to share significant moments from their cancer experience. On the site, www.cancerversary.org, visitors can create a free personalized Web page to share stories and photos, and they can comment on other pages via a guest book feature. A page can also be set up to commemorate a personal “cancerversary,” which acknowledges any significant date or event people choose, and visitors have the option to create a page to honor someone else's cancer experience or pay tribute to someone they've lost to cancer.

Circle Of Sharing is a new social Web application created by the American Cancer Society to help cancer patients, their families, and their friends better coordinate support and cancer information as they move through treatment and beyond. Built on Microsoft HealthVault, a privacy and security enhanced platform designed to help individuals control their personal health information, Circle Of Sharing enables users to share reliable medical information and resources from ACS with a trusted circle of individuals for a more holistic approach to managing their disease.

Patients can organize and access critical details about their diagnosis, medications, other treatments, and side effects all in one secure location, making it easier to keep track of the information and share it with health care providers as they move through the different phases of their treatment.

And, as people record the details of their health, Circle Of Sharing tailors the articles they receive to match their situation. Patients can then share this information with members of their circle to help them better understand the patient's situation. The tool also allows patients and loved ones to send messages to one another to better coordinate support and care. More information can be found online at www.cancer.org/circleofsharing.

Cancer Care Patient Navigation Portal Available on ACCC Web Site

The Association of Community Cancer Centers (ACCC) has launched a new online resource to help cancer programs develop or enhance patient navigation services as part of its “Call to Action” pilot project.

The project is a joint effort by ACCC and the Meniscus Educational Institute of West Conshohocken, PA, aimed at identifying barriers to patient navigation program success, increasing successful implementation of patient navigation services, refining staffing models, and establishing effective metrics for measuring patient navigation services internally, and for benchmarking patient navigation services against other community cancer centers.

The portal, available on the ACCC Web site at www.accc-cancer.org, features pre-assessment forms, intake summaries, referrals forms, patient satisfaction surveys, outcomes measures, and other tools for physicians to sample. A free Webinar for hospitals or practices that want to enhance or expand an existing program is also available on the site, along with an update to ACCC's Cancer Program Guidelines to include patient navigation services, and resources such as navigator job descriptions, tracking forms, and discharge tools.

“Given the complexities of cancer care today, patients need help navigating the path from detection and diagnosis through treatment and beyond,” ACCC Executive Director Christian Downs, JD, MHA, said in a news release. “This is particularly true of traditionally underserved populations where disparities in cancer care are greatest. ACCC's Cancer Care Patient Navigation: ‘A Call to Action’ project reflects ACCC's commitment to ensuring access to quality cancer care in the community setting.”

Led by the International Myeloma Foundation (IMF) and the Myelodysplastic Syndromes Foundation (MDF), a coalition of cancer patient advocacy organizations has issued a “Statement of Principles” regarding issues of reimbursement and access and approval for new and existing cancer treatments.

The principles, revealed at the American Society of Clinical Oncology Annual Meeting, state that:

* Prevention is the key to reducing the burden of cancer.

* Continuing innovation is critical to the early diagnosis and the more effective and safer treatment of the vast majority of patients with cancer.

* Equality of access (and equality of insurance coverage) should be available for all patients to all approved cancer treatments.

* National policies and procedures for early approval of new treatments for cancer and other deadly diseases need to be reformed and streamlined.

* An efficient and effective mechanism is needed to permit access to unapproved and experimental therapies for patients who have exhausted other available possibilities.

“When patients are diagnosed with cancer, their concern should be managing their disease—not reimbursement for their treatments,” Kathy Heptinstall, RN, MDF's Operating Director and Co-founder, said in a news release.

“Oral drugs should have the same coverage as hospital-based procedures; research and innovation must be encouraged and supported; and for fatal diseases, the criteria for drug approvals should emphasize expedited approval and ready access to them.”

“The application of these principles is especially important to patients diagnosed with any of the eight lethal cancers, those that have five-year survival rates of less than 50 percent,” said IMF's President and Co-founder, Susie Novis. “These cancers, including multiple myeloma, will cause nearly half the 560,000 cancer deaths projected in America this year. This is one of the key reasons we must assure that all patients have access to well-trained specialists and that we continue to develop newer, better treatments until there is a cure.”

Mayo Clinic to Establish Facility at Mall of America

Mayo Clinic Rochester has signed a letter of intent to be part of the second phase of expansion of Mall of America in Minneapolis with the aim of reaching new patients and providing services that will enhance, rather than replicate, those currently offered at the Clinic, a news release notes.

“Mayo Clinic's patient population aligns strongly with the Mall of America's guests. Mall of America draws more than 40 million visitors from over 32 countries, and it also has strong nationwide appeal. Likewise, Mayo Clinic is a destination for patients throughout the region, nation and world, so this is a wonderful opportunity to better meet the needs of our patients and build on the synergies of these two Minnesota destinations.”

Over the next 12 months, Mayo Clinic will define how the new facility will complement Mayo's existing presence in Minnesota, he added. “This project builds on Mayo Clinic's tradition of innovation by focusing on the needs of the patient. Mayo strives to create greater value for patients by developing care delivery models based on what patients want and need.”

The US Senate has introduced The Medicare Prompt Pay Correction Act bill (S. 1221) to address problems with Medicare reimbursement for cancer drugs.

Introduced by Senators Arlen Specter (D-PA) and Pat Roberts (R-KS), the legislation is a companion bill to H.R. 1392, which was introduced in the US House of Representatives and currently has 45 co-sponsors.

The bill will amend Title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologics under Part B of the Medicare Program and excludes customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price that artificially reduce Medicare Part B drug reimbursement rates for community oncology clinics, and in turn threaten patient access to affordable, quality cancer care.

Excluding distributor prompt pay discounts from the average sales price methodology is consistent with existing policy and will create greater uniformity among federal healthcare programs. The Medicaid Average Manufacturer Price methodology already excludes these terms.

“Community cancer clinics play a critical role in our nation's fight against cancer, especially in rural areas where families do not have access to larger centers,” Senator Specter said in a news release. “I am pleased to introduce this legislation which will help ensure access for Medicare beneficiaries' to potentially life-saving cancer treatments.”

Fox Chase Launches Institute for Personalized Medicine

Fox Chase Cancer Center has launched the Institute for Personalized Medicine, a program aimed to match emerging targeted drug therapies to the unique genetic profiles of individual patient tumors in order to eliminate the current one-size-fits-all approach to cancer treatment.

“What we think of as personalized medicine is already practiced to great effect with a tiny handful of therapeutics in certain cancers, but the Institute for Personalized Medicine has the potential to expand dramatically both the pool of available drugs and the list of eligible cancer types,” Fox Chase Chief Scientific Officer Jeff Boyd, PhD, said in a news release.

The Institute will build on Fox Chase's Biosample Repository and Tumor Bank, adding an additional layer of new knowledge about the genetic information in individual patient tumors, he said. This information will also be used to accelerate the development of new cancer treatments through collaboration with the cancer center's Phase I Clinical Trials Program.

Initially, the Institute will sequence the tumors of patients new to Fox Chase for a large number of known cancer-related genes, although the hope is that whole-genome sequencing will become standard practice there in a few short years.

“Instead of simply enrolling patients into Phase I trials who have been treated with and failed to respond to every standard treatment, the information we gain in this project may allow us to determine more accurately which patients should be enrolled into which clinical trial,” said Roger B. Cohen, MD, Director of the Phase I Clinical Trials Program.

Fox Chase has made a $2 million commitment to the Institute during the 2010 fiscal year and 12 employees will dedicate the majority of their professional time to it.

Ofatumumab Gets Favorable Recommendation from ODAC

The FDA's Oncologic Drugs Advisory Committee voted 10 to 3 that data on Arzerra (ofatumumab) are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia whose disease is refractory to fludarabine and alemtuzumab. The advisory committee made its decision based on an interim analysis of a pivotal trial of the drug that was presented at the most recent Annual Meetings of the American Society of Hematology (in December) and the American Society of Clinical Oncology (in June).

Banner Health and the University of Texas M. D. Anderson Cancer Center have announced the creation of the M.D. Anderson Banner Cancer Center in Phoenix.

The center, scheduled to open in 2011, will be located on the campus of the Banner Gateway Medical Center there and will feature a 120,000 square-foot cancer outpatient center, modeled after M. D. Anderson's Houston outpatient clinics, and 76 patient beds on two floors inside of Banner Gateway. Services will include medical oncology, radiation oncology, surgical oncology, pathology, laboratory, diagnostic imaging, and other supportive clinical services. M. D. Anderson will have clinical oversight for all aspects of care delivery.

Groundbreaking for the $90 million project is expected to be later this year or early 2010. The M. D. Anderson Banner Cancer Center represents M. D. Anderson's most comprehensive extension of its patient care outside of Houston and is Banner Health's largest collaboration, a news release notes.

Survey: Cancer Pain Worse among Minorities

Consistent and breakthrough pain was found to be worse among ethnic minority cancer patients compared with a comparable group of white patients in a study published in the Journal of Pain and Symptom Management (2009;37:831–847).

Researchers led by Carmen R. Green, MD, Director of the Pain Research Division in the Department of Anesthesiology at the University of Michigan Health System, prospectively analyzed data from a survey of 96 people with Stages III or IV breast, prostate, colorectal, or lung cancer, or Stage II to IV multiple myeloma. Among the respondents, 70% were white and 66% were female.

The surveys, distributed on initial evaluation and at three and six months, assessed consistent pain, breakthrough pain, depressed affect, active coping ability, and health-related quality of life. On a scale of zero to 10, with zero representing no pain and 10, pain at its most severe, non-whites reported scores around 4.75 for consistent pain at its least—numbers similar to white respondents' scores of consistent pain at its worst.

Breakthrough pain also was worse for non-whites than whites. At the three-month point, non-whites reported average scores of about 4.5 for breakthrough pain at its least, compared with an average 2.8 among whites.

“Our findings suggest the burden of cancer pain is unequal, with non-white patients carrying a larger load,” Dr. Green said in a news release.

Regarding measures of pain interfering with activity, mood, walking ability, relationships with others, sleep, and enjoyment of life, non-whites again reported worse pain, with an average score of about 6.1 in the mood category at the start of the study, compared with about 3.8 among whites.

Other quality-of-life measures in the study showed little difference between the two groups, and over the course of the six-month study, the gap in pain scores between non-whites and whites tended to decrease.

The results of the survey also showed that women tended to have higher levels of breakthrough pain than men, and on average, the most recent flares in women were also stronger than in men.

Improving Minority Participation in Clinical Trials

Racial and ethnic minorities and the uninsured, historically underrepresented in clinical trials, are as willing to participate in cancer clinical trials as whites, but they have to be invited, according to data reported at the AACR Annual Meeting.

The collaborative poster study by Meharry Medical College and Vanderbilt Ingram Cancer Center showed that a proactive team approach can successfully identify possible clinical trials for patients and then recruiting them to those trials.

“Our accrual rate is greater than twice the national average,” said first author Debra Wujcik, RN, PhD, Associate Professor of Nursing at Vanderbilt University School of Nursing and Director of the Clinical Trials Office at Meharry for Vanderbilt Ingram Cancer Center.

From 2005–2007, of 566 patients screened, 179 (32%) had a study available and 138 (25%) agreed to participate.

Since the program's inception in 2001, among 1,125 patients screened at Nashville General Hospital, 343 (30%) had a study available and 233 (21%) were enrolled in a clinical trial. Dr. Wujcik said the national standard accrual rate in large academic settings is 5% to 10%.

In the program, being developed as a clinical trial model, nurses screen every cancer patient who comes in to the hospital for any pathologic diagnosis of cancer for an available clinical trial. “Not many places have the resources to that,” Dr. Wujcik said. When the physician sees patients for the first time, the physician has already investigated whether there is trial available.

Principal investigator Samuel Evans Adunyah, PhD, Chair and Professor in the Department of Cancer Biology at Meharry, said the black population in Nashville is about 20%—“so in cities with higher African American populations it should be easier to recruit them into clinical trials.”

Dr. Adunyah said the program is a partnership between Meharry and Vanderbilt-Ingram, developed with a grant from the Minority-Based Community Clinical Oncology Program of the National Cancer Institute to bring together expertise from minority institutions and caner centers.

The FDA has accepted for review Eisai Corporation's supplemental new drug application for an alternative five-day dosing regimen for Dacogen (decitabine) to treat patients with myelodysplastic syndromes (MDS). Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen is for a single daily dose with a significantly reduced administration time.

Acceptance of the application means that the agency has found the company's submission to be sufficiently complete to review.

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